Menopausal Symptoms
Conditions
Keywords
Hot flashes, Menopausal symptoms, Soybean germ, Aglycones, Menopause
Brief summary
Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.
Detailed description
Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein).
Interventions
Sponsors
Nichimo - Tokyo, Japan
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65
Exclusion criteria
Pregnant, BMI\>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flash frequency and severity | — |
Secondary
| Measure | Time frame |
|---|---|
| Menopausal quality of life | — |
Countries
United States
Outcome results
None listed